Why Animal Research?

The future of medicine is bright. Scientific advances are leading to the discovery of newer, better, more targeted medicines that will help treat diseases.

Novartis needs animal research to find innovative, safe and life-saving medicines for patients. Novartis would rather see the end of medical research involving animals. Unfortunately this is not possible today. There are two reasons for that: often, animal studies are needed to better understand complex disease mechanisms; governments and regulatory authorities require that medicines be tested in animals before they are tested in humans.

This is why we must continue with animal research as we look for new medicines for patients.

Regulatory requirements

The health and welfare of human beings is the top priority of all governmental and regulatory organizations around the world. That is why pharmaceutical companies must test their experimental medicines in animals before they are allowed to test them in humans.

The Declaration of Helsinki of the World Medical Association says that it is unethical to give experimental treatments to humans that have not been tested first in laboratory animals. The Declaration is the foundation of many national laws regarding medical research. Healthcare professionals from around the world have signed it.

Every pharmaceutical company is required to submit animal study results for new medicines before starting any studies in humans..

Regulatory authorities in countries around the world require all pharmaceutical medicines to be proven safe and effective. In order to do so, these regulations require every pharmaceutical company to submit animal study results for new medicines before starting any tests in humans. The regulations also require companies to carry out additional longer-term toxicity studies in animals to get approval for a new medicine.

This type of regulation is not unique to the pharmaceutical industry. Legislation has been passed and implemented at national and international levels for a range of substances that could be harmful to animals, humans or the environment.

Past, present and future of animal research

Animal research helps us develop breakthrough medicines. Advances in science are also helping us to reduce and eliminate, where possible, the use of animal research.

Past

Role of animals in medical innovation in the past

Animal research has played a crucial part in bringing medicines to the millions of people who benefit from them every day.

Just how big an impact have these medicines had?

One example: In 1952, there were 58,000 cases of polio caused by infections with the poliovirus in the US. By 2013, due to new vaccines developed with the help of animal research (alongside a dedicated effort to vaccinate children and eradicate the disease) only 406 cases were reported worldwide.

Animal research was critical for scientists like Jonas Salk and Albert Sabin to develop vaccines against polio. These vaccines have saved millions of people from the disabling damage that can result from this disease.

Animal research has also been instrumental in many other medical breakthroughs throughout the twentieth century and into the twenty-first.

During 2013, medicines, vaccines and other products from Novartis were used to treat and protect more than 1.2 billion people worldwide, according to internal estimates.

Present

Role of animals in medical innovation today

Animal research is an essential part of modern research and development (R&D). Pharmaceutical companies are required to test new medicines in animals before they can be safely and ethically tested in human beings.

At present, there is no reliable, systematic alternative to animal testing. Although much research and development can be done in a "test tube" (in vitro), complex disease mechanisms can often only be better understood through the use of animal studies.

Some recent scientific breakthroughs at Novartis in some of the most devastating diseases, such as tuberous sclerosis complex and multiple sclerosis, have benefited in a very direct way from animal research.

Future

Role of animals in medical innovation in the future

The future of medical research is bright with many new types of scientific advances leading the way to the discovery of newer, better, more targeted medicines. The number of animals needed for this research is certainly declining but their importance to the process of medical research is as great as ever.

Some of the new technologies and advances include:

Studying particles in cell cultures, not full living organisms

Cell and tissue "cultures" are groups of cells that are grown outside of the living organism. Using these cell cultures, scientists create an artificial environment for experiments. One area where cell cultures are proving very useful is in experiments on skin. Scientists can test potential medicines that will be applied to the skin to see if they are irritants.

However, using cell and tissue cultures does have its limitations – for example, it does not allow a researcher to see the effect of a substance on the skin on a living body interacting with all its complexities.

Using powerful computer simulations to find pharmacokinetic data

Increasingly advanced computer software programs can now simulate various effects of medicines on the body. These programs are based on criteria that are input into the program about the medicine (for example the absorption rates of a particular medicine).

Using the results of these simulations, scientists are able to see what kind of impact a medicine may have without using animals.

Using transgenic animals

Researchers are now able to use genetic engineering to raise transgenic animals that allow the study of gene function in a living organism.

Transgenic animals are developed by transferring specific genes, including human genes, into animals. In addition to studying normal gene function, transgenic animals are an excellent model to study a gene's role in a disease. They can also serve as in vivo models to test potential new medicines that target a specific gene.

Transgenic animals are a unique and indispensable part of modern medical research for which there are no alternatives.

Reverse vaccinology

Conventionally, vaccine development requires cultivation of a virus or bacteria in animals, followed by its dissection to identify the components important for immunity.

However, in reverse vaccinology, being studied now at Novartis, scientists use gene sequencing to identify certain proteins that are expressed at low levels and during specific circumstances – for example during an infection. These “virulence genes” can then be used to identify candidate vaccine antigens. The use of animal models to test immune response further refines the list of proteins likely to be of use as vaccine antigens. This means that the use of animal studies is greatly reduced and is much more targeted and precise.

Limitations of alternative testing methods

Novartis would rather see the end of animal research if that were possible. Unfortunately, today there is no equivalent substitute for most research involving animals.

We are working to develop alternative research methods to minimize the need for animal testing. These include:

in a "test tube" (in vitro)

other modern scientific methods such as computational modeling and non-invasive analytical methods

Despite the advances made so far, it will still be necessary to continue to use animals for the foreseeable future. This is because the body is very complex with all parts being interdependent on one another. As these interdependencies cannot be recreated in a "test tube" (in vitro) or on a computer, often the only way to find out if a new medicine has unforeseen effects is to test it on a living being.

Animals are used in research and testing when it is necessary to see what happens in the whole living body and the use of human subjects would not be ethically acceptable.

Animal research is, however, only a very small part of all medical research carried out at Novartis. Major progress is being made scientifically to reduce, and perhaps someday eliminate, the need for most animal research while still yielding new, innovative medicines for patients.